eoadjuvant chemotherapy in patients with biliary tract carcinomas - A Nordic phase II study - Nordic-BTC-01

Odense University Hospital0 个研究点目标入组 50 人开始时间: 2014年7月18日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•- Biliary tract carcinoma - cytologically or histologically verified or clinical/radiologically
•- BTC which is considered to be resectable by the treating surgeon i.e. T1-3N0-1M0. The patient must be evaluated at the local HBP-MDT conference
•- The patient is operable (i.e. no co-morbidity which can preclude anaesthesia or sur-gery)
•- WHO performance status 0-1
•- Age = 18 years
•- Adequate haematological, renal, and hepatic function: WBC > 3.0 x 109/l, platelets > 100 x 109/l, creatinine <1.5 x UNL (Upper normal limit), bilirubin <3.0 x UNL, PP % 0,5 – 1,3, APTT < 1,5 x UNL
•- Patients with obstruction of bile duct or gut must be drained before start of therapy
•- Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- No sign of M1 disease
•- No prior radiotherapy to abdominal cavity
•- No pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
•- No sign of other severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
•- No prior chemotherapy for BTC
•- No prior chemotherapy or other oncologic therapy within 12 months

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